Clinical Research Coordinator

Job Overview
We are seeking a dedicated and experienced Clinical Research Coordinator to join our research team.

This role offers an exciting opportunity to be at the forefront of clinical trials, contributing to groundbreaking medical advancements. You will coordinate and oversee clinical research activities, ensure compliance with regulatory standards, and provide exceptional patient care and support throughout the research process. Your proactive approach and attention to detail will help drive successful study outcomes while fostering a positive experience for participants.

Pay is DOE in the clinical research field.

Position is Monday to Friday 8am to 5pm with after hours and weekends when needed.

This is an onsite role and not remote.

Responsibilities

• Assist in the planning, organization, and execution of clinical trials in accordance with FDA regulations, ICH GCP guidelines, and institutional protocols.
• Screen, recruit, and monitor patients or study participants, ensuring adherence to study protocols and maintaining accurate documentation.
• Collect, review, and manage clinical data, including vital signs, blood samples, and other laboratory specimens, utilizing EMR systems.
• Conduct patient assessments such as vital signs measurement, blood sampling (phlebotomy), ECG, and recording medical histories using proper medical terminology.
• Review study documentation for accuracy and completeness; ensure compliance with HIPAA privacy regulations and other applicable standards.
• Manage data collection processes
• Ensure all activities comply with Good Clinical Practice (GCP) standards and maintain up-to-date certifications such as ICH GCP certification.
• Support regulatory submissions by preparing necessary documentation and assisting with audit preparations related to clinical development activities.

Experience

• Strong knowledge of medical terminology, clinical laboratory procedures, and phlebotomy.
• Familiarity with EMR systems, data management tools
• Experience reviewing documentation for accuracy while ensuring compliance with FDA regulations and HIPAA privacy rules.
• Demonstrated ability to monitor patients effectively while maintaining meticulous records of vital signs and other health procedures.
• Ability to troubleshoot and work independently

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Work Location: In person